Lactated Ringers SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL Injection, Solution — NDC 00990-7953-09 package photo

Lactated Ringers SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL Injection, Solution

by ICU Medical Inc. · 12 POUCH in 1 CASE (0990-7953-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG
NDC 00990-7953-09
🏷️ FDA NDC (as labeled) 0990-7953-09 billing pads the labeler segment with a zero
This package
Contains1000 mL in 1 bag Cost per mL$0.0038 NADAC Per package$45.60 / 12000 ml Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.0736/unit — full pricing hub ↓
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Aug 12, 2026 — Presence of Particulate matter. (B BRAUN MEDICAL INC) · FDA recall D-0832-2026
Class I · Apr 28, 2026 — Presence of Particulate Matter. (B BRAUN MEDICAL INC) · FDA recall D-0540-2026
Class I · Aug 18, 2025 — Presence of Particulate Matter (B BRAUN MEDICAL INC) · FDA recall D-0627-2025
Class II · Aug 4, 2025 — Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. (B BRAUN MEDICAL INC) · FDA recall D-0585-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0990-7953-09
Product NDC 0990-7953
11-digit billing NDC 00990795309
NCPDP billing unit ML — per mL (volume)
RxCUI 847627, 847630
UNII 660YQ98I10, TU7HW0W0QT, 451W47IQ8X, LX22YL083G, M4I0D6VV5M
Application # NDA017641
SPL Set ID d310d170-5eeb-471b-af1a-0e845001d21d
Established class (EPC) Blood Coagulation Factor; Cations; Inhibition Larg
Physiologic effect Increased Coagulation Factor Activity; Increased Large Intestinal Motility
Chemical class Calcium; Divalent
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-06-24
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE
GPI-14 79992001202010
GPI class Lactated Ringers
GCN Seq No 001187
GCN 02840
HICL code 000525
Ingredient (HICL) Ringer's Solution,Lactated
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1W
Therapeutic class — specific (HIC3) Electrolyte Maintenance
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name LACTATED RINGERS INJECTION
FDB brand name Lactated Ringers
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 0990-7953-09 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00990-7953-09. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Organic acids class.

Drug family (ATC) Organic acids
How it works Acidifying Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerICU Medical Inc.
Application holderOTSUKA ICU MEDICAL LLC
FDA applicationNDA017641 (NDA)
Labeler code00990
First marketedJun 2019
Product typeHuman Prescription Drug
Portfolio48 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name LACTATED RINGERS INJECTION Ingredient Ringer's Solution,Lactated
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.004 $45.60 / 12000 ml
Medicaid paysCMS SDUD · 12 mo $0.0736 $883.20 / 12000 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J7120 $2.313 / J7120 unit
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.004 $0.003
▲ Up 12% over the last 9 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)0990-7953-09
11-digit billing NDC00990-7953-09
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ7120
DescriptorRINGERS LACTATE INFUSION, UP TO 1000 CC
Billing units / pkg0 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lactated Ringers .6 g/100mL; .31 g/100mL; .03 g/100mL; .02 g/100mL 00264-7750-00 B. 1000 ml $0.004 AP Availability likely
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mLthis 00990-7953-09 ICU 12 pouches $0.004 AP Availability likely
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL 00338-0117-02 Baxter 250 ml AP FDA listed
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL 17271-0710-05 Becton 250 ml AP FDA listed
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 20 mg/100mL; 30 mg/100mL 51662-1516-01 HF 1 pouch AP FDA listed
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL 63323-0164-74 Fresenius 250 ml AP FDA listed
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL 65219-0475-30 Fresenius 250 ml AP FDA listed
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL 65219-0477-20 Fresenius 500 ml AP FDA listed
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL 65219-0479-10 Fresenius 1000 ml AP FDA listed
Lactated Ringers 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL 76420-0129-01 Asclemed 1000 ml AP FDA listed
Lactated Ringers .6 g/100mL; .31 g/100mL; .03 g/100mL; .02 g/100mL 76420-0274-01 Asclemed 1000 ml AP FDA listed
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Jun 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00990-7953-09, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
146.1K
Units reimbursed last 4 qtrs
157.9M
Gross reimbursed last 4 qtrs
$11.62M
Avg / prescription
$79.53
Avg / unit
$0.0736
Latest quarter Q4 2025
26KRx
Medicaid pays / mL
$0.0736
gross reimbursed
vs
NADAC / mL
$0.0038
acquisition cost
=
Spread
+$0.0698
+1837% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
16% FFS 84% MCO
Fee-for-service · 23,626 Rx Managed care · 122,437 Rx
State Medicaid map
Alaska: no data reported AK Maine: 1,450,000 units · 103,943 per 100k residents ME Washington: 378,008 units · 4,839 per 100k residents WA Idaho: 15,737,000 units · 801,273 per 100k residents ID Montana: 785,189 units · 69,363 per 100k residents MT North Dakota: 2,367,002 units · 302,299 per 100k residents ND Minnesota: 2,808,004 units · 48,946 per 100k residents MN Wisconsin: 201,000 units · 3,401 per 100k residents WI Michigan: no data reported MI New York: 13,018,007 units · 66,517 per 100k residents NY Vermont: 1,028,000 units · 158,887 per 100k residents VT New Hampshire: 586,686 units · 41,846 per 100k residents NH Oregon: 4,701,000 units · 111,056 per 100k residents OR Nevada: 2,630,000 units · 82,342 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 20,569,000 units · 641,378 per 100k residents IA Illinois: no data reported IL Indiana: 1,657,000 units · 24,147 per 100k residents IN Ohio: 8,992,000 units · 76,300 per 100k residents OH Pennsylvania: 4,081,003 units · 31,487 per 100k residents PA New Jersey: 487,000 units · 5,242 per 100k residents NJ Massachusetts: 4,082 units · 58.3 per 100k residents MA California: 11,674,065 units · 29,960 per 100k residents CA Utah: 6,312,000 units · 184,723 per 100k residents UT Colorado: 63,000 units · 1,072 per 100k residents CO Nebraska: 10,371,000 units · 524,317 per 100k residents NE Missouri: 2,628,000 units · 42,414 per 100k residents MO Kentucky: 11,280,014 units · 249,227 per 100k residents KY West Virginia: 1,390,000 units · 78,531 per 100k residents WV Virginia: 2,677,000 units · 30,714 per 100k residents VA Maryland: 641,418 units · 10,379 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 2,252,999 units · 106,575 per 100k residents NM Kansas: 1,312,000 units · 44,626 per 100k residents KS Arkansas: 39,000 units · 1,272 per 100k residents AR Tennessee: 1,965,055 units · 27,576 per 100k residents TN North Carolina: 10,657,004 units · 98,357 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 2,840,000 units · 70,072 per 100k residents OK Louisiana: 127,000 units · 2,777 per 100k residents LA Mississippi: 349,059 units · 11,873 per 100k residents MS Alabama: 341,000 units · 6,676 per 100k residents AL Georgia: 3,026,000 units · 27,437 per 100k residents GA D.C.: 61 units · 9.0 per 100k residents DC Hawaii: no data reported HI Texas: 4,928,000 units · 16,156 per 100k residents TX Florida: 1,497,000 units · 6,621 per 100k residents FL
Units reimbursed · per 100k residents
9.0801,273
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Idaho 801,273 /100k
2 Iowa 641,378 /100k
3 Nebraska 524,317 /100k
4 North Dakota 302,299 /100k
5 Kentucky 249,227 /100k
6 Utah 184,723 /100k
7 Vermont 158,887 /100k
8 Oregon 111,056 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
12 pouches this page00990-7953-09 146,063 Rx · $11,615,848
24 pouches00990-7953-03 4,599 Rx · $452,094
24 pouches00990-7953-02 145 Rx · $2,440
Drug total (last 4 qtrs): 150,807 Rx · 162,043,264 units · $12,070,382 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Lactated Ringers — the program that covers self-administered drugs. 4 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Lactated Ringers. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$171.8K
Claims incl. refills
6.2K
Beneficiaries
1.9K
Spend / beneficiary
$89.88
Spend / claim
$27.60
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Lactated Ringers (this brand).

Top reported reactions

Acute Kidney Injury63
Dyspnoea62
Tachycardia53
Blindness50
Hypotension47
Pruritus43
Pain38

Age at onset

Neonate5
Infant55
Child13
Adolescent6
Adult81
Elderly10

Reporter sex

969 reports
Male · 38%
Female · 62%
Unknown · 1%

Serious outcomes

Hospitalization298
Life-threatening117
Death111
Disabling22
Reports over time (by year) — tap or hover for the count & year
2025 2026 4 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00990-7953-02 24 POUCH in 1 CASE (0990-7953-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG 2019-06-24 Active
00990-7953-03 24 POUCH in 1 CASE (0990-7953-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG $0.0038 / mL $45.60 2019-08-01 Active
00990-7953-09 You're viewing this 12 POUCH in 1 CASE (0990-7953-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG $0.0038 / mL $45.60 2019-08-01 Active

This pack effectively ties for the lowest per-mL cost of the 2 priced pack sizes ($0.0038 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 97% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00990-7953-09?
NDC 00990-7953-09 is listed by the FDA — 12 pouch in 1 case / 1 bag in 1 pouch / 1000 ml in 1 bag.
What NDC number is used to bill for this package of Lactated Ringers SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE 600 mg/100mL; 310 mg/100mL; 30 mg/100mL; 20 mg/100mL Injection, Solution?
Bill NDC 00990-7953-09 — the 11-digit billing format is 00990795309. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 32 words

INDICATIONS AND USAGE These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.

⏱️ Dosage and Administration 134 words

DOSAGE AND ADMINISTRATION The dose is dependent upon the age, weight and clinical condition of the patient. As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia. Drug Interactions Additives may be incompatible.

Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. The presence of calcium limits their compatibility with certain drugs that form precipitates of calcium salts, and also prohibits their simultaneous infusion through the same administration set as blood because of the likelihood of coagulation.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .

Contraindications 14 words

CONTRAINDICATIONS Solutions containing lactate are NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS.

⚠️ Warnings 217 words

WARNINGS Solutions containing calcium ions should not be administered simultaneously through the same administration set as blood because of the likelihood of coagulation. Solutions which contain potassium should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.

In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. Solutions containing lactate ions should be used with great care in patients with metabolic or respiratory alkalosis. The administration of lactate ions should be done with great care where there is an increased level or an impaired utilization of lactate ions, as in severe hepatic insufficiency.

The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

🤒 Adverse Reactions 65 words

ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

🔄 Drug Interactions 81 words

Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

The presence of calcium limits their compatibility with certain drugs that form precipitates of calcium salts, and also prohibits their simultaneous infusion through the same administration set as blood because of the likelihood of coagulation. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .

🤰 Pregnancy 66 words

Pregnancy Category C. Animal reproduction studies have not been conducted with Ringer's Injection, USP, Ringer's and Dextrose Injection, USP, Lactated Ringer's Injection, USP or Lactated Ringer's and Dextrose Injection, USP. It is also not known whether these injections can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. These injections should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 86 words

Pediatric Use: The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.

In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolarity and possible intracerebral hemorrhage.

🆘 Overdosage 26 words

OVERDOSAGE In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS .

🧬 Clinical Pharmacology ~2 min read

CLINICAL PHARMACOLOGY When administered intravenously, these solutions provide sources of water and electrolytes with or without minimal carbohydrate calories. Their electrolyte content resembles that of the principal ionic constituents of normal plasma and the solutions therefore are suitable for parenteral replacement of extracellular losses of fluid and electrolytes, with or without carbohydrate calories. Solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories.

Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injected parenterally undergoes oxidation to carbon dioxide and water. Calcium chloride in water dissociates to provide calcium (Ca ++ ) and chloride (Cl − ) ions.

They are normal constituents of the body fluids and are dependent on various physiologic mechanisms for maintenance of balance between intake and output. Approximately 80% of body calcium is excreted in the feces as insoluble salts; urinary excretion accounts for the remaining 20%. Potassium chloride in water dissociates to provide potassium (K + ) and chloride (Cl − ) ions.

Potassium is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 mEq/liter in a healthy adult). It is the chief cation of body cells (160 mEq/liter of intracellular water). Potassium plays an important role in electrolyte balance.

Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion. Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (Cl − ) ions.

Sodium (Na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl − ) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl − ) are largely under the control of the kidney which maintains a balance between intake and output.

Sodium lactate provides sodium (Na + ) and lactate (C 3 H 5 0 3 − ) ions. The lactate anion is in equilibrium with pyruvate and has an alkalizing effect resulting from simultaneous removal by the liver of lactate and hydrogen ions. In the liver, lactate is metabolized to glycogen which is ultimately converted to carbon dioxide and water by oxidative metabolism.

The sodium (Na + ) ion combines with bicarbonate ion produced from carbon dioxide of the body and thus retains bicarbonate to combat metabolic acidosis (bicarbonate deficiency). The normal plasma level of lactate ranges from 0.9 to 1.9 mEq/liter. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight.

Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium.

📦 How Supplied / Storage and Handling 165 words

HOW SUPPLIED These solutions are supplied in single-dose flexible plastic containers as follows: NDC No. Product Name Container Size (mL) 0409-7953-02 Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA Lactated Ringer's Inj., USP 250 0990-7953-02 Lactated Ringer's Inj., USP 250 0409-7953-03 Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA Lactated Ringer's Inj., USP 500 0990-7953-03 , Lactated Ringer's Inj., USP 500 0409-7953-09 , Lactated Ringer's Inj., USP 1000 0990-7953-09 , Lactated Ringer's Inj., USP 1000 0409-7929-03 Lactated Ringer's and 5% Dextrose Inj., USP 500 0990-7929-03 , Lactated Ringer's and 5% Dextrose Inj., USP 500 0409-7929-09 , Lactated Ringer's and 5% Dextrose Inj., USP 1000 0990-7929-09 , Lactated Ringer's and 5% Dextrose Inj., USP 1000 ICU Medical is transitioning NDC codes from "0409" to a"0990" labeler code.

Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: April, 2020 IFU0000184

📋 Description ~2 min read

DESCRIPTION These products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (with or without dextrose) in water for injection. The solutions containing dextrose and electrolytes are hypertonic; those containing only electrolytes are isotonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories.

Each 100 mL of Lactated Ringer's Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na + ), 130 mEq, potassium (K + ) 4 mEq, calcium (Ca ++ ) 3 mEq, chloride (Cl − ) 109 mEq and lactate [CH 3 CH(OH) COO − ] 28 mEq.

The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 − 7.5).

Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g plus the same ingredients and mEq values as Lactated Ringer's Injection, USP (contains only hydrochloric acid for pH adjustment). A liter provides 179 calories (from dextrose and lactate) and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5).

The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. The solutions are parenteral fluid, nutrient and/or electrolyte replenishers.

Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl 2 • 2 H 2 O), white fragments or granules freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.

Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Sodium Lactate, USP is chemically designated monosodium lactate [CH 3 CH(OH)COONa], a 60% aqueous solution miscible in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 O.

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained.

However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. structural formula dextrose structural formula sodium lactate

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.